BURGWEDEL, Germany, Feb. 22, 2018 /PRNewswire/ -- MYR Pharma GmbH today announced the completion of the 48-week-long active treatment phase in MYR 203 clinical trial, a part of Phase 2b program investigating Myrcludex B in combination with pegylated interferon (PEG INF) in chronic hepatitis Delta (HDV) infection. A total of 60 subjects enrolled into this study in 7 centers in Russia were randomized in four groups to receive PEG INF, Myrcludex B monotherapy, and combinations of PEG INF with two different doses of Myrcludex B, respectively.
Commenting on the announcement, MYR Pharma's Chief Medical Officer Dr. Alexander Alexandrov said: "Myrcludex B was very well tolerated with no SAEs attributed to the study drug, confirming the excellent safety profile of the drug that we observed in previous clinical studies." He further commented: "All patients on the combination therapy have by now completed 48 weeks of treatment. We are currently evaluating efficacy readouts from the study."
"Myrcludex B recently demonstrated encouraging results in cirrhotic and interferon non-responder population in MYR 202 clinical trial. The ongoing MYR 203 study will provide an insight as to whether add-on treatments with Myrcludex B can improve suboptimal outcomes of the current standard-of-care interferon treatment," said Heiner Wedemeyer, MD, Professor at the Essen University Hospital and Chairman of MYR Pharma's Clinical Advisory Board.
The patients in MYR 203 are now undergoing a 24-week follow up period. The company expects to announce the results of the study in the mid-2018.
About Myrcludex B
Myrcludex B is a first-in-class entry inhibitor for the treatment of chronic hepatitis B (HBV) and its co-infection hepatitis Delta. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver. Myrcludex has shown an excellent safety profile and antiviral efficacy in several clinical trials. The drug has received Orphan Designation for treatment of HDV infection from the EMA and FDA, and PRIME scheme eligibility from the EMA. Myrcludex B was originally developed at the University of Heidelberg (Germany) and INSERM (France) and is currently one the most clinically advanced novel approaches to the treatment of HBV and HDV.
About MYR GmbH
MYR Pharma GmbH is a German clinical stage biotechnology company focused on the development of drugs for the treatment of chronic hepatitis B and Delta virus infections.
CONTACT: Alexey Eliseev, 1-617-953-0767
Advertisement
Commenting on the announcement, MYR Pharma's Chief Medical Officer Dr. Alexander Alexandrov said: "Myrcludex B was very well tolerated with no SAEs attributed to the study drug, confirming the excellent safety profile of the drug that we observed in previous clinical studies." He further commented: "All patients on the combination therapy have by now completed 48 weeks of treatment. We are currently evaluating efficacy readouts from the study."
Advertisement
"Myrcludex B recently demonstrated encouraging results in cirrhotic and interferon non-responder population in MYR 202 clinical trial. The ongoing MYR 203 study will provide an insight as to whether add-on treatments with Myrcludex B can improve suboptimal outcomes of the current standard-of-care interferon treatment," said Heiner Wedemeyer, MD, Professor at the Essen University Hospital and Chairman of MYR Pharma's Clinical Advisory Board.
The patients in MYR 203 are now undergoing a 24-week follow up period. The company expects to announce the results of the study in the mid-2018.
About Myrcludex B
Myrcludex B is a first-in-class entry inhibitor for the treatment of chronic hepatitis B (HBV) and its co-infection hepatitis Delta. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver. Myrcludex has shown an excellent safety profile and antiviral efficacy in several clinical trials. The drug has received Orphan Designation for treatment of HDV infection from the EMA and FDA, and PRIME scheme eligibility from the EMA. Myrcludex B was originally developed at the University of Heidelberg (Germany) and INSERM (France) and is currently one the most clinically advanced novel approaches to the treatment of HBV and HDV.
About MYR GmbH
MYR Pharma GmbH is a German clinical stage biotechnology company focused on the development of drugs for the treatment of chronic hepatitis B and Delta virus infections.
CONTACT: Alexey Eliseev, 1-617-953-0767
View original content:http://www.prnewswire.com/news-releases/myr-pharma-announces-completion-of-active-treatment-phase-in-myr-203-clinical-trial-of-myrcludex-b-300602851.html
SOURCE MYR Pharma
